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Standardizing real world data, consisting of EHR and claims encounters, into a clinical trial endpoint relies on a complex process of selecting the appropriate data-set and filtering, mapping and merging healthcare encounters from EHR to trial endpoints.This session will describe and appraise approaches and challenges in formulating the endpoints, in both prospective and retrospective research projects, with a focus on cardiovascular endpoints as well as demographic data.

Learning Objectives

Describe process to extract clinical trial endpoints from EHR and claims datasets; Identify how to apply a process to supplement objective EHR and claims dataset endpoints with correlated patient-reported outcomes.

Dr. Richard Gliklich is the CEO of OM1, Inc., an outcomes and technology company focused on real world evidence and measuring and predicting outcomes. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale... Read More →

Debra Harris is the Associate Director of the Center for Pragmatic Health Systems Research at the Duke Clinical Research Institute where she focuses on the use of real-world data for clinical research. She is clinical trial-ist with more than 20 years of data management, cardiovascular... Read More →